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Jun 30, 2023
Bluebird Bio Q2 2023 Earnings Report
Reported financial results for Q2 2023, highlighting commercial and operational progress, and regulatory updates.
Key Takeaways
Bluebird Bio reported a net loss of $72.9 million for the second quarter of 2023. The company's cash, cash equivalents, marketable securities, and restricted cash balance was approximately $291 million as of June 30, 2023. Total revenue, net was $6.9 million for the three months ended June 30, 2023.
Continued strong commercial launch for ZYNTEGLO® and SKYSONA® with 16 patient starts across both programs to date.
Biologics License Application (BLA) for lovo-cel for sickle cell disease accepted for FDA priority review; PDUFA goal date December 20, 2023.
Ended quarter with $291M in cash, cash equivalents, marketable securities and restricted cash.
Company anticipates full-year 2023 cash burn to be in the range of $270-$300 million.
Bluebird Bio
Bluebird Bio
Forward Guidance
Bluebird anticipates full-year 2023 cash burn to be in the range of $270-$300 million. Based on current operating plans, bluebird expects its cash, cash equivalents, marketable securities and restricted cash, inclusive of revenue will be sufficient to meet bluebird’s planned operating expenses and capital expenditure requirements into the fourth quarter of 2024.
Positive Outlook
- Company is on track to scale to 40-50 QTCs by the end of 2023.
- bluebird’s QTC network is designed to maximize its commercial opportunity in beta-thalassemia and to prioritize proximity to individuals with living with SCD in anticipation of a 2024 commercial launch for lovo-cel, if approved by the FDA.
- The Company continues to anticipate 5-10 patient starts this year as previously guided for SKYSONA.
- The FDA has set a PDUFA goal date for December 20, 2023, and if approved, the Company anticipates commercial launch in early 2024 for LOVO-CEL.
- bluebird estimates approximately 20,000 individuals living with SCD (or one-fifth of the U.S. SCD population) may be eligible for gene therapy.
Challenges Ahead
- Company anticipates full-year 2023 cash burn to be in the range of $270-$300 million.
- Excluding $45 million of restricted cash, which is currently unavailable for use, bluebird estimates cash runway into the second quarter of 2024.
- The Company is still operating at a loss, with a net loss of $72.9 million for the quarter.
- Commercialization and manufacturing of products may face delays and challenges.
- The internal and external costs required for ongoing and planned activities may be higher than expected, which may cause the company to use cash more quickly than expected.